December 2022


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
Ilan Kirsch Adaptive Biotechnologies Corp.

regulatory science
Isaac Rodriguez-Chavez ICON plc

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray National Minority Quality Forum

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Sandra Blumenrath, Managing Editor, Scientific Publications DIA Scientific Communications

Chris M. Slawecki, Senior Digital Copyeditor DIA Scientific Communications

Regional Editors

David Mukanga Bill and Melinda Gates Foundation

Jin Shun Sandoz

Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Julie O’Brien Pfizer

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

The Results Reproducibility Gap: A Call to Action
C. Glenn Begley
Biotechnology Consultant

ranslational medicine and precision drug development are plagued by the irreproducibility of fundamental results published in the scientific and medical literature. That irreproducibility is often the result of neglect of the scientific method. In one published study, in 89% of cases, the authors of the original publication were unable to reproduce their preclinical results when the repeated experiments were performed in a “blinded” manner.

Upholding research integrity and improving the quality of research that underpins clinical studies is critically important. This article outlines some of the considerations that could help improve the research enterprise and illustrates the crucial role laboratory scientists play in this endeavor.

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Will Technology Solve the Research “People Problem”?
Clinical trials struggle to enroll eligible patients, while interested patients have difficulty finding pertinent clinical trials. Can technology help solve this people problem? “Typical patient recruitment happens based on historical data at research sites and that usually does not help, given the number of competing clinical trials trying to reach out to the same patients,” explains Indegene Senior Vice President for Enterprise Clinical Solutions Ram Yeleswarapu. “But today, tools and techniques to mine electronic health record data, clinical data, molecular data, allow us to look at sites and patients in a much more precise manner.

“The feedback is positive. As long as you explain the clinical trial, the risk-benefit aspect of being involved in clinical trials, and then make the technology easy and simple to use, very positive feedback is our consensus at this time.”

Updated Good Publication Practice Guidelines: What to Expect in 2023
Lisa DeTora
Hofstra University
Dikran Toroser
Merck & Co. Inc.
Leslie Citrome
New York Medical College

he newest iteration of the Good Publication Practice Guidelines for Company-Sponsored Biomedical Research (GPP) appeared in September 2022 in Annals of Internal Medicine. These guidelines build on prior GPP iterations that bolstered the credibility of publications of company-sponsored research and helped establish the publications profession as a routine function within company-sponsored research.

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Advancing Use and Acceptance of Decentralized Clinical Trials with Digital Elements
Amy Bertha
Patrick Brady
Antoine Manson
Max Wegner
Aneta Woroniecka-Osio
Bayer AG

he pandemic, the war in Ukraine, and other factors have highlighted the need to provide new modern solutions to the way we run clinical trials for the benefit of both patients and healthcare professionals. With the decrease of COVID cases and the possibility for regulators and industry to allocate time and human resources to other topics, now is the time to drive awareness and actively advance the use and acceptance of decentralized clinical trial (DCT) approaches.

A Tale of Two DCTs: Lived Experiences of Both Patient and Caregiver
Jena Daniels

he global virtual clinical trials market is now worth $8 billion, according to Medi-Tech Insights, and is growing at a clip of more than 10% annually. It’s not surprising: Virtual or decentralized clinical trials (DCTs) got their kickstart during the pandemic and have gone mainstream. Are the benefits they promised being realized?

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Successful DCTs: Design Thinking for Optimized Clinical Trials
Bill Byrom
Signant Health

ecentralization of clinical trials is a new term but not a new concept. If we consider the objective of ensuring an empathetic patient experience, optimal trials from the patient perspective may not always be characterized by fewer site visits but should certainly be characterized by a simpler site experience. This benefits both patients and sites. This broader view of trial optimization is important as we design future studies through this wider lens.


Rwanda Welcomes African Medicines Agency Home
While the African Medicines Agency (AMA) plans and plants its inaugural headquarters in Rwanda, the European Commission, the European Medicines Agency (EMA), several EU Member States, and the Bill and Melinda Gates Foundation continue to mobilize more than €100 million in support. “The idea is to use the AMA as a platform that will further advance the capacities of the African continent to regulate medical products as a collective. It’s a network approach to regulation of medical products on the continent,” explains David Mukanga (Deputy Director, Africa Regulatory Systems, Bill and Melinda Gates Foundation) in this conversation with EMA Head of International Affairs Martin Harvey Allchurch.

Around the Globe

Decentralized and Digitalized: Patient-Centric DCTs in China
Alicia He
Takeda Pharmaceutical Company Ltd.
Mia Sun
Pfizer (China) Research & Development Co., Ltd.
On behalf of the DIA China Digital Health Community (DHC)

he concept of DCT is attracting more and more attention in China. The paper Expert Consensus on Decentralized and Digitalized Clinical Trials, jointly written by the DIA China Digital Health Community (DHC) and Shanghai Pharmaceutical Association, was recently published (in Chinese) in the Chinese Journal of New Drugs and Clinical Remedies. DCT stands for not only decentralized clinical trial but also digitalized clinical trial in China.

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Around the Globe

A Viable European Union Medicines Regulatory System Must be a Cornerstone for Innovation in Europe
Mark Mayer
Eli Lilly
Nick Sykes
Julie O’Brien

Sini Eskola
Magda Chlebus

European Federation of Pharmaceutical Industries and Associations (EFPIA)
Chloé Garay
Eli Lilly, on secondment to EFPIA

he European Union (EU) regulatory system has been a model of collaboration and innovation over many decades. In the current environment of rapidly advancing science, growing demands on data science expertise, and geopolitical changes, insufficient resources limit the EU regulatory system’s global competitiveness. This hinders the expertise-based decision making necessary to deliver new medicines for EU patients as effectively and efficiently as possible.


Why Trans/Nonbinary Research Benefits All Communities
Liam Paschall
Actions to increase patient diversity in clinical research initially addressed racial and ethnic demographics but are expanding to address gender identity. “Further research can only help us better understand the differences in our bodies and illnesses and how combinations of certain medications and existing treatments can improve everyone’s lives,” explains Liam Paschall (Parexel, TransCanWork, DEIBA thought leader). “This will not only help transgender people. It’s going to teach us about how the human body works.

“Transgender people need to be included in clinical research to decrease discrimination, to improve education, to improve treatment for every person, not just transgender people. When people know better, they’re expected to do better. And while it’s important that we do continue to have these discussions, and I want us to continue to educate each other, it’s really time at this point for action.”

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We Are DIA
DIA Congratulates Our 2022 Japan Award Winners

Our 2022 Japan Inspire Award Winners

Picture of Nobumasa Nakashima
Nobumasa Nakashima
Pharmaceuticals and Medical Devices Agency (PMDA)
Picture of Takashi Sato
Takashi Sato
Kyowa Kirin Co., Ltd.
Picture of Aya Suzuki
Aya Suzuki
Taiho Pharmaceutical Co., Ltd.
Thanks for reading our December 2022 Issue!
Views and opinions expressed in Global Forum are those of the authors alone and do not necessarily represent those of DIA or any other agency, organization, employer, or company. DIA does not guarantee the accuracy or completeness of any information published in Global Forum and will not be responsible for any errors, omissions, or claims for damages, including exemplary damages, arising out of use, inability to use, or with regard to the accuracy or sufficiency of the information contained in Global Forum.